Cimetidine

ANDA 75285, held by L Perrigo Co. Cimetidine.

As of Nov 14, 2026, ANDA 75285 (Cimetidine), held by L Perrigo Co, was first approved by FDA on Oct 29, 1998, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1998
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 29, 1998	Original application	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cimetidine200MG · tablet;oral	Cimetidine	OTC

All 9 submissions, including labeling and manufacturing supplements


Feb 21, 2020	Supplement 44Labeling · Standard review	Approved	None posted
Feb 27, 2009	Supplement 30Labeling	Approved	None posted
Jan 22, 2003	Supplement 8Labeling	Approved	None posted
Nov 5, 2001	Supplement 6Labeling	Approved	None posted
Jun 11, 2001	Supplement 5Labeling	Approved	None posted
Jun 10, 1999	Supplement 3Labeling	Approved	None posted
Apr 13, 1999	Supplement 2Labeling	Approved	None posted
Jan 25, 1999	Supplement 1Labeling	Approved	None posted
Oct 29, 1998	Original application	Approved	Letter Review

Identifiers

Application: ANDA 75285
Drugs@FDA: Overview at FDA
Company: L. Perrigo Company

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters